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Sounds great – doesn’t it?

Or does it sound too good to be true?

It all comes down to perspective and expectations.

If these words evoke the idea of a magic pill

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

image in your mind – i.e. all I have to do is spend some money here and boom, my child will be potty trained in one day – that’s it – s/he will go from diapers/pul

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

l-ups to potty training pants and will not have accidents and we will all live happily ever after.

Well, a magic pill it is not!! It will take effort and energy on

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

your part and yes, you will have to clean up accidents. We all learn from our mistakes and your child will not be any different.

It is however a proven method tha

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

has successfully worked for many parents. The one day is the “Big Day” (see Figure 1 below). This is the day when the actual potty training is done and your child

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

will give up diapers forever and start using “big kid” potty training pants.

PREPARATION & PLANNING===>"THE BIG DAY"===>THE FOLLOW UP

Figure 1: The Potty Training

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

in One Day Process - modified for this article

(The preparation & planning can take from 1 hour to 2 week or more, depending on your and your child's readi

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ness. The "Big Day" is the day you potty train your child - and it take anywhere from an hour to the whole day. The follow-up can take anywhere from 0-2 weeks dep

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

nding on your child.)

However, as many other things in life, in order for you to have a pleasant and successful “Big Day” you will have to spend some time preparin

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

g and planning for this day. The planning and preparation could take anywhere from one hour to a few weeks depending on how ready you and your child are. The time r

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

equired for the follow-up after the “Big Day” really depends on your child. Some children do not require any follow-up, but others may require more.

So, what is Po

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

tty Training in One Day?

It is a proven method to potty train your child; Your child will give up diapers on this day and will learn to pee on the potty and will a

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

so learn what is expected of him/her as far as going to the potty goes.

You on the other hand; will have to expend some time, effort and energy before this day by

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

getting all the supplies together and then preparing your child and yourself for this day (you are already doing this by reading this article!!). You will have to m

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

entally and physically get ready to handle potty accidents and clean ups from these potty accidents. After the big day, you will also have to clean up more potty ac

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

cidents and follow up with your child and make sure that s/he is clear on what you expect from him/her.

Most people who choose to use this method are surprised by

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ow quickly their child learns and that the potty accidents are limited to a few days. Most children will be accident free in one week, however, you have the ones th

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

at never have accidents, and then you have the ones that will have accidents for a couple of weeks.

Stick with it and your child will be accident free in t

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

"_new" href="http://www.pottytrainingconcepts.com/Potty-Training.htm">How to Potty Train in One Day from Potty Training Concepts - www.PottyTrainingConcepts.co

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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